Prima starts recruiting for ovarian cancer trial
Prima BioMed (ASX:PRR) has commenced recruitment for its revised phase II trial of drug candidate CVac in ovarian cancer.
The first patient has been enrolled in the CAN-004 trial and recruitment is underway across 16 sites in Europe. More sites are due to commence recruitment shortly.
Prima aims to enrol 210 epithelial ovarian cancer patients in remission after second-line platinum-based chemotherapy. The primary endpoint will be overall survival; secondary endpoints include progression-free survival, adverse events and immune monitoring.
The company plans to manufacture CVac for all European clinical trial sites from its manufacturing facility in Leipzig, Germany, in collaboration with the Fraunhofer Institute for Cell Therapy and Immunology.
Last year, Prima re-evaluated the design of the upcoming trial based on data from its CAN-003 study which indicated there won’t be a significant impact on progression-free survival.
CAN-004’s primary endpoint was thus changed from progression-free to overall survival, the number of planned patients was cut back and the focus was shifted from patients in remission after first-line therapy to those in remission after second-line therapy.
Several European regulatory agencies, including Belgium’s Federal Agency for Medicines and Health Products, have now signed off on the amended protocol.
Prima BioMed (ASX:PRR) shares were trading 5.71% higher at $0.037 as of around 1 pm on Monday
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